Baxter International issues urgent correction for certain software versions of infusion pumps
The false alarm may lead to an interruption or delay of therapy, and Baxter has received three reports of serious injury potentially associated with this issue, the regulator said.
Deerfield: Medical device maker Baxter International has issued an urgent correction for certain software versions of its infusion pumps that deliver fluids into a patient's body, the U.S. drug regulator said on Monday.
The correction has been issued due to an increase in reported false blockage alarms following the software upgrades in SIGMA Spectrum and Spectrum IQ infusion pumps, the U.S. Food and Drug Administration said.
Shares of the company, which manufactures dialysis products and infusion pumps, fell 2.5% in morning trade.
The false alarm may lead to an interruption or delay of therapy, and Baxter has received three reports of serious injury potentially associated with this issue, the regulator said.
The company is contacting affected customers to schedule the software reversion, the FDA said, adding that they can continue to use the devices by following certain on-screen instructions to troubleshoot the issue.
Baxter did not immediately respond to Reuters' request for a comment.
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